JVT Advisors

Quality Associate

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Location: Durham, North Carolina 02142
Employment Type: Contract

Job Description

Quality Associate

Durham, NC (RTP)

6 + Months

As part of the IT Quality team, deliver technically robust and compliant GxP computerized systems (CS) that withstand audits, both internal and external. The Quality Associate III is expected to have working-level knowledge of CS validation, including the quality systems supporting it (i.e., change management, exceptions management, risk management). Foundational and executable regulatory expectations for CS. Works with peers locally to ensure practices are consistent with requirements and expectations set forth within the governing QMS.

Duties Include:

  • Support the compliant implementation of GxP computerized systems (i.e., new, upgrades, changes, etc.) to ensure the approach and execution aligns to industry as well as Biogen expectations through the review and approval of life cycle deliverables.
  • Under the guidance of management, perform supporting quality related activities associated with computerized systems including periodic reviews, change management, risk management, etc. for assigned systems in alignment with noted KPIs.
  • Under the guidance of management, provide quality assurance oversight for system related issues (deviations, incidents, etc.)
  • Perform all assigned and required trainings to maintain 100% compliance.
  • Bachelor’s Degree (BS) from a four (4) year college or university with as emphasis in Engineering, Life Sciences or IT related discipline with relevant experience. Advanced degree preferred.
  • 5+ years related experience and/or training with a least 2 years in a CSV/Quality role. Background in Lifesciences and/or Pharma/Biotech Industries:

 

Trevor Hoffman

Technical Recruiter

Trevor recruits for JVT's Life Sciences and Technology Practices where he specializes in finding, screening, and placing top-tier industry innovators at companies across multiple markets and verticals.

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